Ignite Creation Date:
2024-05-06 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05093634
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2021-09-30
Brief Title:
EMANATE A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Sponsor:
Rhythm Pharmaceuticals Inc
Organization:
Rhythm Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Trial Multiple Independent Sub-studies of Setmelanotide in Patients With POMCPCSK1 LEPR NCOA1SRC1 or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The protocol describes a randomized double-blind placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway
POMC or PCSK1 Sub-study 035a
LEPR Sub-study 035b
SRC1 Sub-study 035c
SH2B1 Sub-study 035d
The objectives and endpoints are identical for these sub-studies
POMC or PCSK1 Sub-study 035a
LEPR Sub-study 035b
SRC1 Sub-study 035c
SH2B1 Sub-study 035d
The objectives and endpoints are identical for these sub-studies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None